A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart (Pall-Heart)

November 3, 2020 updated by: Jill Howie Esquivel, PhD, University of Virginia

Heart failure is common in adults and is the most common hospital diagnosis in older adults. Patients with heart failure suffer numerous distressing symptoms daily. Although palliative care can improve suffering, rural-dwelling heart failure patients have poor access to specialized palliative care. The investigators propose to pilot test a tele-health palliative care intervention, PALL-HEART, in rural dwelling heart failure patients who live in Virginia and Kentucky.

Study specific objectives are:

Primary Aims:

  • AIM 1: Compare HF patients who participate in a home-delivered tablet-based HF health education and gentle stretching intervention, to a health education (HE) group on: a) HF symptoms (weight gain, breathlessness, fatigue), b) psychological symptoms (depression, diminished QOL, resilience, self-care, and heart rate variability), c) physical function (endurance, strength, balance), and d) health care utilization rates (ED visits, office visits, hospitalizations).
  • Hypothesis 1: HF symptoms (weight gain, breathlessness, fatigue), psychological symptoms (depression, diminished QOL, resilience, self-care), physical function (endurance, strength, balance) will improve in the intervention group.
  • Hypothesis 2: Health care utilization rates (ED visits, office visits, hospitalizations) will decrease in the intervention group.

Secondary:

  • AIM 2: Acceptability - Acceptability of the intervention will be determined using: a) participation and satisfaction rates (participant logs), b) intervention retention rates, and c) barriers to participation (technology and participant motivation issues).
  • Hypothesis: Subjects in the intervention group will have >80% participation and satisfaction rates and be willing to identify barriers to participation.

acceptability of the intervention for future refinement and large scale testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Heart failure with reduced ejection fraction or Heart failure with preserved ejection fraction as seen by problem list in the EMR, is a patient in the heart failure clinic, or general cardiology clinic.
  • ability to read, write and understand English;
  • agree to participate and give informed consent;
  • 19 years of age and older;
  • telephone access;
  • and NYHA class I-III with no changes in medications in 30 days (i.e. medical therapy is optimized).

Exclusion Criteria:

  • are pregnant and/or breast feeding (self-reported)
  • have a history of non-adherence with medications (as described by their provider or medical record);
  • have had a hospitalization within the last 3 months for HF;
  • have unstable angina; CABG, MI or biventricular pacemaker less than 6 weeks prior;
  • have orthopedic impediments to stretching exercise;
  • have severe COPD with a forced expiratory volume in one second less than 1 liter as measured by spirometry;
  • have severe stenotic valvular disease;
  • have a history of resuscitated sudden cardiac death without subsequent placement of an implantable cardioverter defibrillator;
  • exercise more than 3 times weekly; currently engage in yoga at least 1 time per week;
  • have cognitive impairment (as measured by the Mini-Cog)
  • are living in a nursing home
  • history of pulmonary arterial hypertension (PASP>60mmHg)
  • other serious life-limiting co-morbidity, e.g. end stage cancer
  • post-heart transplant (s/p OHT) or Left Ventricular Assist Device (LVAD)
  • New York Heart Association Functional Class IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Educational Control Group
Education provided for optional use
Experimental: Gentle Stretching and Education
Gentle Stretching for 60 minutes twice weekly
Behavioral: Gentle Stretching
60 minutes fo gentle stretching twice weekly for 8 weeks
Other Names:
  • Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Somatic Perception Scale Questionnaire
Time Frame: 10 weeks
This questionnaire measures symptoms of heart failure - The 18-item Somatic Perception Scale asks participants how much they are bothered by 18 symptoms of heart failure in the past week using 5 response options ranging from 0 (I did not have the symptom) to 5 (extremely bothersome). Scores are summed, with higher values indicating higher symptom burden. Scores range from 0-90 with higher values indicating higher symptom burden.
10 weeks
PROMIS questionnaire
Time Frame: 10 weeks
This questionnaire screens for symptoms of depression. The 8-item questionnaire assesses self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) in the past week. The questionnaire uses 5 response options ranging from 0 (never) to 5 (always). Scores are summed, with higher values indicating higher risk for depression. The total raw score is converted into a T-score. The T-score rescales the raw score into a standardized score. The final score is a standardized score with a mean of 50 and a standard deviation of 10.
10 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 10 weeks
This questionnaire measures quality of life in people with heart failure. This questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Overall scores are transformed to a range of 0-100, in which higher scores reflect better health status. There are summary scores within the KCCQ and the overall summary score is created by the mean of Physical Limitation Score, Total Symptom Score, Quality of Life Score, and Social Limitation Score.
10 weeks
The Resilience Scale
Time Frame: 10 weeks
The Resilience Scale is a 25-item administered questionnaire that measures an individual's ability to adapt over time to stressors in life. Scores on the summated scale range from 25 to 175, with higher scores indicating higher resilience. All of the items are positively worded. Items are measured on a 7-point scale from 1(strongly disagree) to 7 (strongly agree). Responses are summed to produce a total score where a higher score indicates higher resilience.
10 weeks
Self-Care for Heart Failure Index Questionnaire (SCHFI)
Time Frame: 10 weeks

The Self-Care for Heart Failure Index Questionnaire (SCHFI) is a 39-item measure of heart failure self-care. The items range from never (1) to always (5). There are 3 subscales: maintenance scale, symptom perception, confidence scale, and management scale. All of the scales are scored in the same way and a total score is not computed. Separate scores for each scale are computed separately.

In general, to standardize a scale score, 1) determine the maximum possible scale score, 2) subtract the number of items from the possible score, and 3) divide 100 by that result to identify a constant for that scale. To score the scale, sum item responses, subtract the number of items answered, and multiply by the constant.The higher the score, the greater the ability to care for heart failure symptoms within each subscale.
10 weeks
Endurance
Time Frame: 10 weeks
2 step test - step alternating knees upward for 2 minutes
10 weeks
upper body strength - we will measure bicep strength by the number of hand weight lifts
Time Frame: 10 weeks
participants are instructed to perform as many arm curls as possible for 30 seconds
10 weeks
lower body strength - we will measure quadricep strength by the number of times siting and standing in 30 seconds
Time Frame: 10 weeks
participants are instructed to sit and then to stand as many times as possible in 30 seconds
10 weeks
balance
Time Frame: 10 weeks
stand on 1 leg for as long as possible
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with investigators who request the dataset. No individual personal or HIPPA identifiers will be shared.

IPD Sharing Time Frame

when data are analyzed and for 5 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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